The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

14951–14975 of 29202

  • SevereFDA (Drugs)·D-0272-2018·2018-02-07

    Medline DC Line Kit Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling DC Line Kits because the iodine concentration in the prep pads is below the labeled claim.

    Product
    Medline DC Line Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0282-2018·2018-02-07

    Medline Recalls Subpotent Povidone-Iodine Prep Pads

    Medline Industries is recalling sterile staple remover trays containing subpotent povidone-iodine prep pads. The iodine concentration is below the labeled claim of 0.85%.

    Product
    Medline Staple Remover Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60060
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0560-2018·2018-02-07

    FDA Recalls Unapproved Clalis Capsules Containing Sildenafil

    A&H Focal Inc. is recalling Clalis capsules because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0317-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling 9,000 cases of Suture Removal Trays because the iodine concentration in the prep pads is below the labeled claim.

    Product
    Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0266-2018·2018-02-07

    Medline Central Line Dressing Change Tray Kit Recalled for Subpotent Iodine

    Medline is recalling Central Line Dressing Change Tray Kits because the iodine concentration in the prep pads is below the label claim.

    Product
    Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0309-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.

    Product
    Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0271-2018·2018-02-07

    Medline General Purpose Kit Recalled for Subpotent Povidone-Iodine

    Medline Industries is recalling General Purpose Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.

    Product
    Medline General Purpose Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0260-2018·2018-02-07

    Medline Recalls Pediatric IV Kits With Subpotent Iodine Concentration

    Medline Industries is recalling Pediatric IV Kits because the Povidone-Iodine prep pads contain less iodine than labeled.

    Product
    Medline Pediatric IV Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0265-2018·2018-02-07

    Medline Recalls IV Start Kits With Subpotent Povidone-Iodine

    Medline Industries is recalling IV Start Kits because the Povidone-Iodine prep pads contain less iodine than labeled.

    Product
    Medline IV Start Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0291-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Povidone-Iodine

    Medline Industries is recalling suture removal trays because the povidone-iodine prep pads contain less iodine than labeled.

    Product
    Medline Straight Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0318-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than labeled.

    Product
    Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0568-2018·2018-02-07

    FDA Recalls Unapproved Power V8 Viagra Tablets Containing Sildenafil

    A&H Focal Inc. is recalling Power V8 Viagra tablets because they contain sildenafil, an unapproved drug with unestablished safety and efficacy.

    Product
    Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0273-2018·2018-02-07

    Medline Dressing Change Tray Kit Recalled for Subpotent Iodine Content

    Medline Industries is recalling Dressing Change Tray Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.

    Product
    Medline Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V095000·2018-02-07

    Keystone Recalls 2018 Crossroads Sunset Trailers Due to Incorrect Tires

    Keystone RV is recalling 2018 Crossroads Sunset trailers because they may have tires with an incorrect load rating, which could lead to tire failure and a crash.

    Product
    CROSSROADS — CROSSROADS SUNSET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0700-2018·2018-02-07

    Claudio Specialty Foods Recalls Anchovy Sauce Due to High Histamine Levels

    Claudio Specialty Foods is recalling specific lots of Sapori di Mare Colatura di Alici di Cetura anchovy sauce because the product contains high levels of histamine.

    Product
    Sapori di Mare Colatura di Alici di Cetura; Anchovy Sauce; 100 ml, Lot #'s 03/2017 or 09/2017.
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·008-2018·2018-02-06

    Olymel Recalls Raw Pork Products Lacking Import Inspection

    Olymel S.E.C./L.P. is recalling approximately 4,618 pounds of raw pork products because they were imported from Canada without undergoing required U.S. import re-inspection.

    Product
    Olymel S.E.C./ L.P. Recalls Pork Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·18V090000·2018-02-02

    Jaguar Recalls 2018 Models for Fuel Rail Leak Fire Risk

    Jaguar is recalling 2018 XE, XF, E-PACE, F-PACE, and F-TYPE vehicles because fuel rail end caps may leak, increasing the risk of a fire.

    Product
    JAGUAR — JAGUAR E-PACE, F-TYPE, XF, F-PACE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·007-2018·2018-02-01

    Whip City Jerky Recalls Beef Jerky for Undeclared Milk Allergen

    Whip City Jerky is recalling beef jerky products because they contain milk, a known allergen, that is not declared on the label.

    Product
    Whip City Jerky, LLC — Whip City Jerky, LLC Recalls Beef Jerky Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·18V087000·2018-02-01

    Land Rover Recalls 2018 Models for Fuel Rail Leak Fire Risk

    Jaguar Land Rover is recalling 2018 Discovery Sport, Range Rover Evoque, and Velar vehicles because fuel rail end caps may leak, increasing the risk of a fire.

    Product
    LAND ROVER — LAND ROVER DISCOVERY SPORT, RANGE ROVER EVOQUE, RANGE ROVER VELAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0635-2018·2018-01-31

    Pharmatech Recalls Leader Liquid Multivitamin for Yeast Contamination

    Pharmatech LLC is recalling Leader Liquid Multivitamin Supplement for Infants and Toddlers due to the presence of yeast and potential contamination with B. cepacia.

    Product
    Leader Liquid Multivitamin Supplement for Infants and Toddlers 50 mL UPC 096295128611
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0620-2018·2018-01-31

    Rugby Liquid Vitamin C Supplement Recalled for Yeast and B. cepacia

    Pharmatech LLC is recalling Rugby Liquid Vitamin C Supplement 500 mg due to the presence of yeast and potential contamination with B. cepacia.

    Product
    Rugby Liquid Vitamin C Supplement 500 mg 118 mL UPC 00536-0160-97
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0626-2018·2018-01-31

    Rugby D3 Vitamin Liquid Recalled for Yeast and B. cepacia Contamination

    Pharmatech LLC is recalling Rugby D3 Vitamin liquid due to the presence of yeast and potential contamination with B. cepacia.

    Product
    Rugby D3 Vitamin liquid 400 IU/1 mL dose 1 2/3 fl. oz. (50 mL) UPC 00536-8400-80
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0611-2018·2018-01-31

    Fresh-Pak Sliced Apples Recalled for Listeria Contamination

    Fresh Pak, Inc. is recalling 9oz containers of sliced apples potentially contaminated with Listeria monocytogenes.

    Product
    9oz Mix (red/green) Slice Apples Container - Fresh-Pak brand. 1 unit per case
    Category
    Food
    Distribution
    3 states